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FDA 510(k)

BREATHE EASY

K-Number: K914336 · 1992-03-25

ApplicantVital Signs, Inc.
Decision Date1992-03-25
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATHE EASY is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1992-03-25 under 510(k) number K914336. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHE EASY?

BREATHE EASY is a medical device that received FDA 510(k) clearance on 1992-03-25. The listed applicant is Vital Signs, Inc.. The 510(k) number is K914336.

When did BREATHE EASY receive FDA 510(k) clearance?

BREATHE EASY received FDA 510(k) clearance on 1992-03-25, under 510(k) number K914336.

Who is the listed applicant for BREATHE EASY?

The FDA 510(k) record lists Vital Signs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREATHE EASY?

The FDA product code for BREATHE EASY is BYD.

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Other records listing Vital Signs, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK021315SURE-LOKK002454BREAS HA50 HUMIDIFIER, MODEL HA50

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Related Devices (Code: BYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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